AccessGUDID - DEVICE: PALAMIX® (04260102133587)

GUDID

Device Identifier (DI) Information

Brand Name: PALAMIX®
Version or Model: UNO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66057893
Company Name: Heraeus Medical GmbH

Primary DI Number: 04260102133587
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333623937 *Terms of Use

Device Description: PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing system PALAMIX® uno and PALAMIX® duo allow for automatic collection of bone cement within the mixing cartridge under vacuum.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61468	Manual orthopaedic cement mixer, single-use	A sterile hand-operated device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically consists of a vessel with attached/attachable mixing blades where the cement is mixed. It may include a plunger unit used to transfer the mixed cement from the vessel into an applicator prior to the surgical procedure, and a suction tube to enable connection to a separate fume extraction device. It is typically operated outside of the sterile surgical field and is not intended to contact the patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDZ	Mixer, Cement, For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a15a0f9a-543c-4e41-935b-b75fd98b5517
Public Version Date: May 13, 2019
Public Version Number: 4
DI Record Publish Date: March 16, 2018